Effect of Honey for CIN II

Last updated: February 10, 2025
Sponsor: Zuyderland Medisch Centrum
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Precancerous Condition

Genitourinary Cancer

Treatment

Medical grade honey formulation (MGH) (L-Mesitran®)

Medical grade honey formulation (MGH) (L-Mesitran®)

Clinical Study ID

NCT06219018
NL86044.096.23
  • Ages 18-40
  • Female
  • Accepts Healthy Volunteers

Study Summary

The following hypothesis is tested: Medical grade honey in CIN II causes a higher clearance of the hr-HPV virus and an increase in the normalization of CIN II lesions compared to expectant management.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Women 18-40 years

  • Primary CIN II confirmed histologically in the biopsy on colposcopic examination

  • Sufficient mastery of the Dutch language

Exclusion

Exclusion Criteria:

  • Simultaneous abnormality in columnar epithelial cells (AIS).

  • Hr-HPV negative cytology

  • Immunosuppressant use/Autoimmune disease (HIV, CVID)

  • History of cervical carcinoma or previous treatment for CIN (LLETZ or imiquimod)

  • Pregnancy or the intention to become pregnant during the study period

  • Legal incompetence

  • Known allergies to honey

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Medical grade honey formulation (MGH) (L-Mesitran®)
Phase: 1
Study Start date:
December 30, 2024
Estimated Completion Date:
December 01, 2027

Study Description

In this pilot study, we will include 60 patients with newly diagnosed CIN II. Patients will be counseled according to standard guidelines between a LLETZ, imiquimod or expectant management. Patients choosing for expectant management will be asked to participate in the study and will be treated with medical grade honey. Patients choosing for expectant management but not participating in the study and thus not using medicinal honey will be asked for the control arm. Follow-up assessment takes place in accordance with the national guideline (first check-up is after 6 months). In addition, swabs for vaginal microbiota analysis will be taken at 0 and 6 months. Immunohistochemical stainings for the local immune infiltrate will be performed on biopsies taken during regular colposcopy at t=0. This exploratory study assesses the potential effect of honey and provides insight into its mechanisms of action.

Connect with a study center

  • Zuyderland MC

    Heerlen, Limburg 6149 PC
    Netherlands

    Active - Recruiting

  • Maastricht University Medical Centre+

    Maastricht, Limburg 6229 HX
    Netherlands

    Site Not Available

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